FDA.reportPublic FDA data

Dental appliance fabrication material, ceramic

Definition
A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
GUDID devices
103,101
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00197998024252Solventum™Solventum Germany GmbH699402026-05-08
00197998024306Solventum™Solventum Germany GmbH699522026-05-08
00197998024313Solventum™Solventum Germany GmbH699512026-05-08
00197998024320Solventum™Solventum Germany GmbH699502026-05-08
00197998024337Solventum™Solventum Germany GmbH699492026-05-08
00197998024344Solventum™Solventum Germany GmbH699462026-05-08
00197998024351Solventum™Solventum Germany GmbH699452026-05-08
00197998024368Solventum™Solventum Germany GmbH699442026-05-08
00197998024375Solventum™Solventum Germany GmbH699412026-05-08
00197998024382Solventum™Solventum Germany GmbH699422026-05-08
00197998024399Solventum™Solventum Germany GmbH699432026-05-08
00197998024405Solventum™Solventum Germany GmbH699472026-05-08
00197998024412Solventum™Solventum Germany GmbH699562026-05-08
00304040170151Henry ScheinHENRY SCHEIN, INC.57034022023-08-08
00304040170168Henry ScheinHENRY SCHEIN, INC.57034032023-08-08
00304040170175Henry ScheinHENRY SCHEIN, INC.57034042023-08-08
00304040170182Henry ScheinHENRY SCHEIN, INC.57034052023-08-08
00810222551248PIXELSTONE™DIGITAL ARCHES INC.A1 / 20mm2026-04-29
00810222551255PIXELSTONE™DIGITAL ARCHES INC.A1 / 25mm2026-04-29
00810222551262PIXELSTONE™DIGITAL ARCHES INC.A2 / 20mm2026-04-29
00810222551279PIXELSTONE™DIGITAL ARCHES INC.A2 / 25mm2026-04-29
00810222551286PIXELSTONE™DIGITAL ARCHES INC.B1 / 20mm2026-04-29
00810222551293PIXELSTONE™DIGITAL ARCHES INC.B1 / 25mm2026-04-29
00810222551309PIXELSTONE™DIGITAL ARCHES INC.OM3 / 20mm2026-04-29
00810222551316PIXELSTONE™DIGITAL ARCHES INC.OM3 / 25mm2026-04-29
00817340023404Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr A1 14mm Frame 2pk2021-11-08
00817340023411Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr A2 14mm Frame 2pk2021-11-08
00817340023428Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr A3 14mm Frame 2pk2021-11-08
00817340023435Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr A3.5 14mm Frame 2pk2021-11-08
00817340023442Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr A4 14mm Frame 2pk2021-11-08
00817340023459Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr B1 14mm Frame 2pk2021-11-08
00817340023466Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr B2 14mm Frame 2pk2021-11-08
00817340023473Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr B3 14mm Frame 2pk2021-11-08
00817340023480Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr B4 14mm Frame 2pk2021-11-08
00817340023497Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr C1 14mm Frame 2pk2021-11-08
00817340023503Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr C2 14mm Frame 2pk2021-11-08
00817340023510Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr C3 14mm Frame 2pk2021-11-08
00817340023527Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr C4 14mm Frame 2pk2021-11-08
00817340023534Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr D2 14mm Frame 2pk2021-11-08
00817340023541Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr D3 14mm Frame 2pk2021-11-08
00817340023558Imagine ZirconiaJENSEN INDUSTRIES INC.Imagine X TRAN Zr D4 14mm Frame 2pk2021-11-08
00817340023572Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono A1 14mm Frame 2pk2020-05-04
00817340023589Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono A2 14mm Frame 2pk2020-05-04
00817340023602Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono A3.5 14mm Frame 2pk2020-05-04
00817340023619Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono A4 14mm Frame 2pk2020-05-04
00817340023626Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono B1 14mm Frame 2pk2020-05-04
00817340023633Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono B2 14mm Frame 2pk2020-05-04
00817340023664Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono C1 14mm Frame 2pk2020-05-04
00817340023671Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono C2 14mm Frame 2pk2020-05-04
00817340023688Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono C3 14mm Frame 2pk2020-05-04
00817340023718Jensen XT ZirconiaJENSEN INDUSTRIES INC.Jensen XT TRAN Zr Mono D3 14mm Frame 2pk2020-05-04
00817477020031CGICERAGROUP INDUSTRIES INC.COGLP12020-06-16
00817477020062CGICERAGROUP INDUSTRIES INC.CFLLFS2020-06-16
00817477020079CGICERAGROUP INDUSTRIES INC.CFLLFL2020-06-16
00817477020086CGICERAGROUP INDUSTRIES INC.CFLLFX2020-06-16
00817477020123CGICERAGROUP INDUSTRIES INC.TSTPA2020-06-16
00817477020147CGICERAGROUP INDUSTRIES INC.TSTPC2020-06-16
00817477020154CGICERAGROUP INDUSTRIES INC.TSTPD2020-06-16
00817477020161CGICERAGROUP INDUSTRIES INC.TSTPBK2020-06-16
00817477020178CGICERAGROUP INDUSTRIES INC.TSTPBU2020-06-16
00817477020215CGICERAGROUP INDUSTRIES INC.TSTPOC2020-06-16
00817477020246CGICERAGROUP INDUSTRIES INC.TSTPVT2020-06-16
00817477020253CGICERAGROUP INDUSTRIES INC.TSTPWT2020-06-16
00817477020260CGICERAGROUP INDUSTRIES INC.TSTPYL2020-06-16
00817477020277CGICERAGROUP INDUSTRIES INC.PSGK092020-06-16
00817477020406CGICERAGROUP INDUSTRIES INC.COSA2S2020-06-16
00817477020420CGICERAGROUP INDUSTRIES INC.COS35S2020-06-16
00817477020444CGICERAGROUP INDUSTRIES INC.COSB0S2020-06-16
00817477020475CGICERAGROUP INDUSTRIES INC.COSB3S2020-06-16
00817477020482CGICERAGROUP INDUSTRIES INC.COSB4S2020-06-16
00817477020499CGICERAGROUP INDUSTRIES INC.COSC1S2020-06-16
00817477020536CGICERAGROUP INDUSTRIES INC.COSD2S2020-06-16
00817477020543CGICERAGROUP INDUSTRIES INC.COSD3S2020-06-16
00817477020550CGICERAGROUP INDUSTRIES INC.COSD4S2020-06-16
00817477020567CGICERAGROUP INDUSTRIES INC.COSMKS2020-06-16
00817477020871CGICERAGROUP INDUSTRIES INC.TGINLS2020-06-16
00817477020925CGICERAGROUP INDUSTRIES INC.TAODMS2020-06-16
00817477020932CGICERAGROUP INDUSTRIES INC.TAODDS2020-06-16
00817477020949CGICERAGROUP INDUSTRIES INC.TAOICS2020-06-16
00817477020956CGICERAGROUP INDUSTRIES INC.TAOILS2020-06-16